Evaluation Of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration For Suspected Pancreatic Neoplasms

Study Overview

Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms

We aim to compare the efficacy (diagnostic yield), ease of use, and technical success rates of EUS guided 22 gauge fine needle aspiration to core biopsy in the evaluation of pancreatic tumors. The experimental hypothesis is that FNA will have superior overall diagnostic yield than core biopsy.

Background: Endoscopic ultrasonography (EUS) has been utilized for over a decade to evaluate endo-luminal and adjacent tumors of the gastrointestinal tract. In that time, EUS guided fine needle aspiration (FNA) has emerged as the dominant means of tissue acquisition for pancreatic mass lesions. FNA has several limitations, foremost of which is the absence of a clear relationship between cellular elements and stroma which may be required for accurate diagnosis. Additionally, EUS-FNA requires the assistance of an on-site cytopathologist for optimal yield which limits its dissemination and increases its cost. A novel EUS histology needle (EUS-FNB) is available in the 22 gauge diameter which may allow for more accurate diagnosis without the need for on site cytopathology assistance. Aim: To prospectively compare the diagnostic yield, number of needle passes, and ease of use of 22 gauge EUS-FNA and EUS-FNB. Hypothesis: EUS-FNB is superior to traditional EUS-FNA with regard to all primary and secondary outcome measures. Methods: Patients scheduled for EUS evaluation of solid pancreatic tumors will be screened for enrollment at either a preceding clinical encounter or the morning of their scheduled procedure. English-speaking patients between the ages of 18 and 90 with a predominantly solid (greater than 60%) mass lesion of the pancreas will be considered for enrollment. Exclusion criteria include pregnancy, a predominantly cystic lesion, and the presence of an uncorrectable coagulopathy. Patients will then undergo both EUS-FNA and EUS-FNB for the collection of tissue specimens required for clinical care. The results of the experimental approach (EUS-FNB) will be compared to the control approach (EUS-FNA). Data collected for each procedure will include: instrument use order, number of needle passes with each device, technical success of each device, complications, ease of use, and the ultimate pathological diagnosis / diagnostic yield for each device. Each data category will then be compared utilizing standard statistical tests including chi-squared, Fishers' exact, or student's t test.

Pancreatic Tumor

DEVICE: Fine Needle Aspiration (FNA) and Core biopsy (FNB)

15779

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-08-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-02-20
First Submitted that Met QC Criteria 2012-08-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-02-22
First Posted (ACTUAL) 2012-08-27	Results First Posted N/A	Last Verified 2024-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Fine Needle Aspiration and Core Biospsy Patients will undergo both FNA and core biopsy during EUS evaluation of a solid pancreatic tumor.	DEVICE: Fine Needle Aspiration (FNA) and Core biopsy (FNB)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Fine Needle Aspiration and Core Biospsy

Patients will undergo both FNA and core biopsy during EUS evaluation of a solid pancreatic tumor.

DEVICE: Fine Needle Aspiration (FNA) and Core biopsy (FNB)

Primary Outcome Measures	Measure Description	Time Frame
Diagnostic Yield		One-week post procedure

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Age greater than 18 and less than 90 years.
Presence of a solid (greater than 60%) mass lesion within the pancreas on cross-sectional imaging, without a preceding tissue diagnosis.
Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not correct with the administration of fresh frozen plasma.
The patient must read and speak english and has signed informed consent document.
The patient is scheduled for diagnostic endosonography by their referring provider or UVa gastroenterologist.

Age less than 18 or greater than 90 years.
The patient is unable to read or understand the consent form.
The patient is currently pregnant.
The patient has an uncorrectable coagulopathy as defined by a prolonged prothrombin time (PT) or partial thromboplastin time (PTT) which does not improve with administration of fresh frozen plasma.
The patient has a pancreatic mass lesion which is predominantly cystic (greater than 40%).
No mass lesion is identified at the time of endosonography.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Vanessa Shami, MD, University of Virginia

Publications

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Clinical Trial Record